BoneFit: A Student-led Multimodal Prehabilitation Service for Orthopaedic Surgical Patients in Hull
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Recruitment
研究概览
简要总结
To conduct a pilot feasibility study to determine the effect of a student-led prehabilitation service in people awaiting total hip or knee replacement surgery.
详细描述
The aim of BoneFit is to provide local people living in the Hull region with a needs-based prehabilitation care package to improve their physical and mental health, quality of life & reduce their length of hospital stay, complications and readmission rates to hospital following orthopaedic surgery (total hip replacement, or total knee replacement.
Currently, Hull University Teaching Hospitals do not offer a prehabilitation service for local patients. The University of Hull will partner with them to provide a student-led multimodal prehabilitation service for referred patients awaiting orthopaedic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Masking is not possible - referrals/care providers know whether they/referral is involved in the intervention or not.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Waiting for unilateral total hip or knee replacement surgery for a minimum of 6 months;
- •Able to provide informed consent;
排除标准
- •Previous hip or knee surgery;
- •Any medical conditions for which moderate to vigorous exercise is contraindicated;
- •Patellar or hip joint instability;
- •Any other disease/condition which severely effects functional performance e.g. stroke or Parkinson's disease;
- •Chronic depression or significant psychiatric disorder;
- •Enrolled in a clinical trial (or recently completed one);
- •Cognitive impairment which would affect compliance to BoneFIt service;
- •Patients unable or unwilling to commit to required study follow-ups
- •Pregnancy;
研究组 & 干预措施
BoneFit intervention
Participants will receive a personalised care plan comprising exercise, nutrition and psychological wellbeing based on individual need in the 8-week period prior to surgery
干预措施: Experimental: BoneFit intervention (Behavioral)
Control
Participants who are allocated to this group will receive baseline tests and will be invited to re-attend 3 months post surgery to re-do tests. This group will receive usual care (no intervention). The groups will be compared.
干预措施: Placebo Comparator: Control (Behavioral)
结局指标
主要结局
Recruitment
时间窗: 2 years
Number of people recruited and trained
Adherence and attendance
时间窗: 2.5 years
Record the number of sessions attended and calculate adherence to protocol (%)
Acceptability
时间窗: 3 years
Conduct semi-structured interviews following the intervention with sample of participants and ask them about experiences of the intervention. The post-intervention interviews will focus on how participants viewed the intervention, perceived burdens, and perceived effectiveness from initiation through to completion. A list of burdens / perceived benefits will be reported alongside percentage rates of respondents.
次要结局
- Readmission rates(3 years)
- Length of stay(3 years)
- Physical fitness(3 years)
- Overall quality of life(3 years)
- Knee or hip specific pain, function and quality of life(3 years)